Method and devices for flow occlusion during device exchanges

Abstract

A method for facilitating treatment of catheter induced vascular injuries may first involve introducing a guide wire into a vascular sheath residing in a blood vessel, where the guide wire has a distal end and an inflatable balloon at least 15 cm proximal of the distal end. The method may further involve proximally retracting the vascular sheath while leaving the wire in place and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may involve positioning the inflatable balloon at or near the vascular injury and inflating the balloon to reduce blood flow past the vascular injury, while leaving the guide wire in place to provide subsequent access to the injury.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 13 / 531,227, entitled “Method and Devices for Flow Occlusion During Device Exchanges,” filed on Jun. 22, 2012, which claims priority to U.S. Provisional Patent Application Ser. Nos. 61 / 501,125, entitled “Methods and Devices for Flow Occlusion During Device Exchanges,” filed on Jun. 24, 2011; and 61 / 540,994, entitled “Method and Devices for Flow Occlusion During Device Exchanges,” filed on Sep. 29, 2011. The full disclosures of these references are hereby incorporated by reference.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The field of the present application pertains to medical devices, and more particularly, to methods and systems for maintaining vascular access and / or minimizing bleeding, for example, during and after catheter-based interventions, for example, in the settings of device exchanges, vascular access closure, and the management of vasc...

AI Technical Summary

Benefits of technology

This approach minimizes blood loss, facilitates quicker vascular repair, and provides immediate stabilization of injuries, reducing clinical sequelae and the need for emergency surgeries by allowing for efficient delivery of treatment devices directly to the injury site.

Problems solved by technology

Although these procedures may often be effective at treating the condition addressed, they often cause injury to the blood vessel in which the large bore vascular access catheter is inserted to gain access for performing the procedure.

If not properly treated, such a vascular injury may lead to anemia, hypotension or even death.

Vascular injury during large bore intravascular procedures is typically caused by the vascular access sheath itself and / or one or more instruments passed through the sheath to perform the procedure.

Several other factors may increase the risk of vascular injury, including occlusive disease of the access vessel(s) and tortuosity / angulation of the access vessel(s).

Another vascular injury caused by large bore intravascular procedures that can be challenging is the access site itself.

This may lead to significant blood loss while access closure is attempted.

Despite the availability of these techniques, vascular injury requiring treatment still occurs in a large percentage of large bore vascular procedures.

Vascular injuries caused by intravascular procedures are generally quite difficult to diagnose and treat.

The dissected vessel wall may lead to a breach in the artery wall, a flow-limiting stenosis, or distal embolization.

Generally, vascular perforations and dissections caused by large bore vascular procedures allow very little time for the interventionalist to react.

Frequently, these vascular injuries are associated with serious clinical sequelae, such as massive internal (retroperitoneal) bleeding, abrupt vessel closure, vital organ injuries, and emergency surgeries.

Thus, the procedure is quite challenging and cumbersome.

Although considered the standard of care in the management of vascular complications, the CBOT technique may not provide immediate stabilization of an injured segment, may lack ipsilateral device control, and / or may not provide ready access for additional therapeutics such as stents, other balloons and the like.

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